Are you looking for an exciting opportunity in the field of safety data management and pharmacovigilance? IQVIA, a global leader in advanced analytics, technology solutions, and contract research services, is seeking an Operations Specialist 2 to join our dynamic team in Kolkata, India. This role offers the chance to work in a collaborative environment where you can utilize your expertise in safety data processing and contribute to critical pharmaceutical projects.
About the Company:
IQVIA™ is a company committed to providing innovative solutions to the healthcare industry, empowering organizations with the insights necessary to optimize their business performance. We specialize in providing a range of services, including real-world evidence, clinical development, and safety management. Join us to be part of a culture that values your contribution while driving advancements in healthcare.
Job Overview:
As an Operations Specialist 2, you will leverage your expertise in pharmacovigilance and safety data management to assess, process, and oversee safety data across various service lines. This position requires exceptional decision-making capabilities and offers the opportunity to mentor junior staff members while managing small to medium operational projects.
Key Responsibilities:
- Safety Data Processing: Review, assess, and process safety data in compliance with applicable regulations, guidelines, and standard operating procedures (SOPs).
- Pharmacovigilance Activities: Collect and manage incoming Adverse Events (AEs), perform database entries, coding, narrative writing, and ensure case closure according to project timelines.
- Regulatory Compliance: Assess safety data for reportability, liaise with relevant stakeholders, and prepare submissions to regulatory authorities.
- Team Collaboration: Build a positive team environment, provide mentorship, and communicate effectively with project teams and management.
- Training and Development: Participate in training activities and contribute to the implementation of new initiatives for process efficiencies.
Qualifications:
- Education: Bachelor’s Degree in a scientific or healthcare discipline or allied life sciences.
- Experience: Up to 5 years of relevant experience, with at least 3 years in pharmacovigilance preferred.
- Skills: Excellent knowledge of medical terminology, advanced proficiency in safety databases, and strong organizational skills.
- Communication: Outstanding verbal and written communication abilities, along with effective mentoring and project management skills.
